PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT— 510(k) K942583
Substantially EquivalentBio-Vascular, Inc.
FDA 510(k) clearance K942583 for PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT, Substantially Equivalent on 1994-07-08. Applicant: Bio-Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Vascular, Inc.
- Product code
- Code FTL
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FTL
view allMore clearances from Bio-Vascular, Inc.
view all- K002233 — BVI SLING
- K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
- K983602 — CV PERI-GUARD AND VASCU-GUARD
- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
Adverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.